510(k) Report

FDA product code · General and plastic surgery

Device, Anastomotic, Microvascular

MVRClass II21 CFR 878.4300510(k) required9 decisions since 19862 recalls

9 FDA decisions since 1986. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K093310, named by 3 later devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of MVR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MVR

2in 2019

2009: 12010: 12013: 12014: 12015: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVR

Too few MVR 510(k)s in any year since 2007 to give a median.

Recalls per year · MVR

1in 2020

2008: 12020: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MVR

91in 2025

2007: 12008: 122009: 232010: 312011: 282012: 292013: 212014: 262015: 402016: 222017: 132018: 132019: 442020: 432021: 352022: 182023: 282024: 382025: 91
2007high 91 (2025) · low 1 (2007)2025

MAUDE reports naming product code MVR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—112
20091—023
20101—031
20110—028
20120—029
20131—021
20141—026
20151—040
20160—022
20170—013
20180—013
20192—044
20200—143
20210—035
20220—018
20230—028
20240—038
20250—091
20260—0—
FIG. 1 — MVR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MVR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4300.